Risk Management Lead
2 meses atrás
BeiGene is seeking a highly motivated and experienced Risk Management Lead to join our team. As a key member of our quality management team, you will be responsible for providing onboarding training and tools to assigned teams, facilitating risk management with stakeholders, and collaborating with cross-functional teams to analyze risks and issues.
Key Responsibilities- Develop and implement risk management strategies to ensure compliance with regulatory requirements and company policies.
- Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, and process owners to analyze risks and issues using quality performance data.
- Develop and maintain documentation of risk management activities, including risk/issue tracking and resolution.
- Trend risks and issues across related entities and support the study team in optimizing controls applied based on risk evaluation.
- Support the study team in optimizing the RBQM model and develop and lead culture change and communication activities with stakeholders.
- Conduct ad hoc risk assessments as needed to support clinical development.
- 8+ years of experience leading risk assessments in the pharmaceutical industry or equivalent.
- Prior experience deploying risk-based quality management programs across clinical development preferred.
- Ability to work independently to complete management and oversight activities.
- Experience working and communicating within cross-functional teams.
- Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data.
- Therapeutic area specific experience and knowledge – Oncology/Hematology preferred.
- Ability to use relevant technology and risk-based tools/platforms effectively.
- Proven track record in delivering agreed results against a plan and timeline.
- Understanding of ICH and regulatory environment.
0-20% travel required.
BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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